RESUMO
Objetivo. Evaluar la efectividad y seguridad del fingolimod en la práctica clínica habitual en la región de Asturias y Cantabria (España). Pacientes y métodos. Estudio retrospectivo y multicéntrico de pacientes con esclerosis múltiple recurrente remitente tratados con fingolimod, según la ficha técnica. La efectividad se evaluó en los pacientes con al menos un año de tratamiento. Se calculó la tasa anualizada de brotes (TAB), el porcentaje de pacientes libres de brotes y libres de lesiones captantes de gadolinio, y los que mejoraron/mantuvieron la puntuación en la escala expandida del estado de discapacidad (EDSS). Se analizó la población total y según el tratamiento previo: inmunomodulador (interferón beta-1 o acetato de glatiramero) o natalizumab. Resultados. Un total de 138 pacientes iniciaron tratamiento con fingolimod; el 60% recibió previamente inmunomodulador; el 28%, natalizumab; y el 9%, ningún tratamiento. Noventa y nueve pacientes estuvieron al menos un año en tratamiento con fingolimod. Después de un año de tratamiento, el fingolimod disminuyó la TAB en un 67% (1,26 a 0,42; p < 0,0001), aumentó el porcentaje de pacientes libres de brotes de un 24% a un 69% (p < 0,0001), y el porcentaje de pacientes libres de lesiones captantes de gadolinio de un 70% a un 85% (p < 0,0106). El 77% de los pacientes mejoró/mantuvo la puntuación en la EDSS. Resultados similares se observaron en pacientes tratados previamente con inmunomodulador. La efectividad de los pacientes tratados previamente con natalizumab se mantuvo tras el tratamiento con fingolimod. Conclusiones. La práctica clínica habitual en las regiones de Asturias y Cantabria muestra que el fingolimod tiene resultados similares a los observados en los ensayos clínicos, al comparar las variables clinicorradiológicas utilizadas en estos últimos (AU)
Aim. To evaluate the effectiveness and safety of fingolimod in routine clinical practice in the region of Asturias and Cantabria (Spain). Patients and methods. We conducted a retrospective multicentre study of patients with relapsing-remitting multiple sclerosis treated with fingolimod, in accordance with the product data sheet. Effectiveness was evaluated in patients with at least one years treatment. The following were calculated: annualised relapse rate (ARR), the percentage of patients free from relapses and free from gadolinium-enhancing lesions, and those who improved/maintained their score on the Expanded Disability Status Scale (EDSS). Both total population and according to previous treatment: immunomodulator (interferon beta-1 or glatiramer acetate) or natalizumab, were analysed. Results. A total of 138 patients started treatment with fingolimod; 60% previously received an immunomodulator; 28% were given natalizumab; and 9% had no treatment. Ninety-nine patients were treated with fingolimod for at least one year. After one year of treatment, fingolimod decreased the ARR by 67% (1.26 to 0.42; p < 0.0001), increased the percentage of patients free from relapses from 24% to 69% (p < 0.0001) and the percentage of patients free from gadoliniumenhancing lesions from 70% to 85% (p < 0.0106). Altogether, 77% of the patients improved/maintained their score on the EDSS. Similar results were observed in patients previously treated with an immunomodulator. The effectiveness of the patients previously treated with natalizumab remained the same following treatment with fingolimod. Conclusions. Routine clinical practice in the regions of Asturias and Cantabria shows that fingolimod yields similar results to those observed in clinical trials, on comparing the clinicoradiological variables used in them (AU)
Assuntos
Humanos , Masculino , Feminino , Cloridrato de Fingolimode/uso terapêutico , Avaliação de Medicamentos , Cloridrato de Fingolimode/farmacologia , Esclerose Múltipla/tratamento farmacológico , Espanha , Estudos RetrospectivosRESUMO
INTRODUCTION: Recent studies have shown the need to optimise the management of patients after a first attack suggestive of multiple sclerosis (MS). Our aim is to determine whether the results from follow-ups in these studies are reproducible within a Spanish multi-centre context. PATIENTS AND METHODS: The PREM study (observational prospective Spanish multi-centre study at 24 months) included patients in the first three months following a first event suggestive of MS with at least two typical lesions in a magnetic resonance scan. The Expanded Disability Status Scale (EDSS) was obtained and the presence of attacks was evaluated basally and at 3, 6, 9, 12, 18 and 24 months; a magnetic resonance scan was performed basally and at 6 and 24 months so as to be able to calculate the brain volume and the volumes of the lesions (T1, T2 and T1 after administering gadolinium). McDonald and Poser criteria were evaluated during the follow-up. A subgroup of patients was followed up for a total period of four years. RESULTS: Altogether 110 patients (67% females) with a mean age of 30.2 years were included in the study; 22 patients dropped out of the study before it finished. Poser criteria were met by 19% and 45% of patients at 6 months and 24 months, respectively; 63% and 71% satisfied McDonald criteria. The EDSS decreased significantly (-0.94; p < 0.001) and development of atrophy was observed (-1.2%; p < 0.001) at 24 months. CONCLUSIONS: Results of the follow-up of patients with first attacks suggestive of MS within a Spanish multi-centre context are wholly comparable with those from international clinical trials performed in these patients.
Assuntos
Esclerose Múltipla/patologia , Esclerose Múltipla/fisiopatologia , Adulto , Estudos de Coortes , Avaliação da Deficiência , Progressão da Doença , Feminino , Seguimentos , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/diagnóstico , Estudos Prospectivos , Índice de Gravidade de Doença , Espanha , Taxa de Sobrevida , Adulto JovemRESUMO
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